enfortumab vedotin (Padcev)

Brand Names: Padcev

Generic Name: enfortumab vedotin

• What is enfortumab vedotin (Padcev)?
• What are the possible side effects of enfortumab vedotin (Padcev)?
• What is the most important information I should know about enfortumab vedotin (Padcev)?
• What should I discuss with my healthcare provider before receiving enfortumab vedotin (Padcev)?
• How is enfortumab vedotin given (Padcev)?
• What happens if I miss a dose (Padcev)?
• What happens if I overdose (Padcev)?
• What should I avoid while receiving enfortumab vedotin (Padcev)?
• What other drugs will affect enfortumab vedotin (Padcev)?
• Where can I get more information (Padcev)?

Enfortumab vedotin is used to treat cancer of the bladder or urinary tract in adults.

This medicine is used when the cancer is advanced, has spread to other parts of the body (metastatic), or cannot be removed with surgery.

Enfortumab vedotin is usually given after other treatments such as immunotherapy or platinum cancer medicine.

Enfortumab vedotin may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have symptoms of high blood sugar:

• increased thirst, dry mouth, fruity breath odor;
• increased urination,
• confusion, drowsiness; or
• nausea, vomiting, stomach pain, loss of appetite.

Also call your doctor at once if you have:

• numbness, tingling, or burning pain in your hands or feet;
• pain, redness, and peeling skin on your hands or feet;
• a severe skin rash with itching, scaling, or blisters;
• severely dry eyes, vision problems; or
• redness, itching, swelling, or discomfort where the medicine was injected.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• numbness or tingling;
• muscle weakness;
• feeling tired;
• nausea, loss of appetite, diarrhea;
• rash, dry skin;
• hair loss; or
• changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Tell your doctor if you have ever had:

• numbness or tingling in your hands or feet;
• diabetes; or
• high blood sugar.

Enfortumab vedotin can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use enfortumab vedotin if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using enfortumab vedotin.

This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because enfortumab vedotin can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 3 weeks after your last dose.

Enfortumab vedotin is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when enfortumab vedotin is injected.

Enfortumab vedotin is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

Enfortumab vedotin can cause high blood sugar (hyperglycemia) even if you have never had it before or if you are not diabetic. Severe hyperglycemia may be life-threatening. Your blood sugar may need to be checked often.

Enfortumab vedotin can also cause dry eyes. Your doctor may tell you to use artificial-tear eye drops to help prevent dry eyes.

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Call your doctor for instructions if you miss an appointment for your enfortumab vedotin injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Some drugs can affect your blood levels of enfortumab vedotin, which may increase side effects. Tell your doctor about all your other medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.

Your pharmacist can provide more information about enfortumab vedotin.

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